BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE WRENCH

    MDR report key: 9078650 · Received September 17, 2019

    Report

    Report Number
    1526439-2019-52101
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Report Date
    August 27, 2019
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HXC
    UDI-DI
    10705034196770
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. INVESTIGATION SUMMARY: THE TORQUE WRENCH [PRODUCT CODE: 2770-40-510, LOT NUMBER: BV698171] WAS NOT RETURNED TO THE COMPLAINT HANDLING UNIT (CHU). INSTEAD, THE SAMPLE WAS RETURNED TO 5 STAR FOR REWORK AND RECALIBRATION. FIVE STAR SURGICAL, INC HAS PERFORMED THE TORSIONAL TEST FOR THE TORQUE WRENCH AND PROVIDED THE RESULTS TO THE COMPLAINTS HANDLING UNIT. TORQUE WRENCH WAS TESTED FOR TORSIONAL TEST PER TM-100331, REV 15 FOR MOUNTZ AND TELEDYNE TORQUE SERVICE LIMIT RANGE: (55.8 - 64.2 IN-LBS), (74.4 - 85.6 IN-LBS.) AND (93 - 107 IN-LBS.) ON A TORQUE METER (GAGE ID#: 78862). SIX READINGS WERE RECORDED AT EACH TORQUE SETTING. IT WAS NOTED THAT THE HANDLE WAS TORQUING ABOVE THE UPPER SPECIFICATION LIMIT (USL) OF (55.8 - 64.2 IN-LBS.) RANGE A REVIEW OF THE RECEIVING INSPECTION (RI) FOR TORQUE WRENCH WAS CONDUCTED. AS A RESULT, THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. ALL COMPLAINT TRENDS WILL BE EVALUATED AS A PART OF THE DEPUY SPINE MONTHLY COMPLAINT REVIEW MEETING. A DEFINITIVE ROOT CAUSE FOR THE TORQUE WRENCH OVER TORQUING CANNOT BE POSITIVELY DETERMINED. ALTHOUGH NOT PROVEN, THE MOST PROBABLE ROOT CAUSE FOR THE OVER TORQUING OF THE HANDLE CAN BE ATTRIBUTED TO LACK OF MAINTENANCE DURING ITS TIME IN USE, RESULTING IN THE TORQUE HANDLE EXERTING MORE TORQUE THAN ITS UPPER SPECIFICATION LIMIT (USL) OF (55.8 - 64.2 IN-LBS.) RANGE. NO CORRECTIVE ACTION/PREVENTIVE ACTION (CAPA) IS NECESSARY NOW AS NO ISSUES WERE IDENTIFIED IN THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THEREFORE, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW / INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND / OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AUGUST 28, 2019, THE TORQUE CALIBRATION FAILURE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TORQUE DRIVER. THIS IS REPORT 10 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869316 TORQUE WRENCH WRENCH HXC DEPUY SPINE INC 277040510 BV698171 10705034196770

    Patients

    Seq Age Sex Outcome Treatment
    1